System and Method for Sterilization of Medical Instruments within a Hydrogen Peroxide Sterilization Process

ABSTRACT

A system and method of sterilization for medical instruments within a hydrogen peroxide sterilization process is provided. A medical instrument is housed in a sterilization tray, wherein the sterilization tray is formed from polypropylene and a glass material. The medical instrument and sterilization tray are subjected to a hydrogen peroxide sterilant.

CROSS REFERENCE TO RELATED APPLICATION

This application claims benefit of U.S. Provisional Application Ser. No.62/149,032, entitled, “System and Method for Sterilization of MedicalInstruments Within a Hydrogen Peroxide Sterilization Process” filed Apr.17, 2015 and U.S. Provisional Application Ser. No. 62/166,994, entitled,“System and Method for Sterilization of Medical Instruments Within aHydrogen Peroxide Sterilization Process” filed May 27, 2015, the entiredisclosure of which is incorporated herein by reference.

FIELD OF THE DISCLOSURE

The present disclosure is generally related to sterilization of medicalinstruments and more particularly is related to a system and method forsterilization of medical instruments within a hydrogen peroxidesterilization process.

BACKGROUND OF THE DISCLOSURE

The sterilization of medical instruments and tools before, after, andsometimes during medical procedures is a foundation of modern healthcare, as it is imperative in preventing the spread of harmfulcontaminants. Commonly, medical instruments are held withinsterilization trays which are then processed through a sterilizationoperation. The sterilization operation can include sterilization withinan autoclave, which is a pressure chamber that subjects the medicalinstruments to high pressure saturated steam at approximately 250°F.-270° F. for a period of time. Other sterilization processes includethe use of chemical sterilant or light-based sterilizing devices.

Sterilization trays used within the medical industry are commonlymanufactured from polyphenylsulfone (PPSU) often known by the brand nameRADEL®. The PPSU utilizes an extrusion process combined with athermoforming process or is injection molded from resin. These PPSU haveproven successful in many types of sterilization processes, such aswithin steam autoclave, but they have points of failure in lowtemperature sterilization processes. For example, low-temperaturechemical sterilizing using hydrogen peroxide has become more commonplacewhen sterilizing medical instruments that cannot tolerate steamsterilization. When the PPSU is subjected to hydrogen peroxidesterilization, however, the hydrogen peroxide is absorbed and causes thePPSU to discolor and become brittle over time, which leads to trayfailure, or worse, ineffective sterilization due to a drop in theconcentration level of hydrogen peroxide in the sterilization chamber.

Thus, a heretofore unaddressed need exists in the industry to addressthe aforementioned deficiencies and inadequacies.

SUMMARY OF THE DISCLOSURE

Embodiments of the present disclosure provide a system and method forsterilization of medical instruments within a hydrogen peroxidesterilization process. Briefly described, in architecture, oneembodiment of the method, among others, can be broadly summarized by thefollowing steps: housing a medical instrument on a sterilization tray,wherein the sterilization tray is formed from polypropylene and a glassmaterial; and subjecting the medical instrument and sterilization trayto a hydrogen peroxide sterilant. The sterilization tray may be formedfrom polypropylene and the glass material by first injection molding thepolypropylene and the glass material into a sheet form and thenthermoforming the sheet form of the polypropylene and the glass materialinto a tray form. In one of many alternatives, the sterilization traymay be formed from polypropylene and the glass material by injectionmolding the polypropylene and the glass material into a tray form.

The present disclosure can also be viewed as providing methods ofmanufacturing and using a sterilization tray. In this regard, oneembodiment of such a method, among others, can be broadly summarized bythe following steps: combining a quantity of polypropylene with a glassmaterial; injecting the combined quantity of polypropylene with glassmaterial into a sheet form; thermoforming the sheet form of the combinedquantity of polypropylene with glass material into a tray form, therebyproviding a sterilization tray; and subjecting the sterilization tray toa hydrogen peroxide sterilant.

Other systems, methods, features, and advantages of the presentdisclosure will be or become apparent to one with skill in the art uponexamination of the following drawings and detailed description. It isintended that all such additional systems, methods, features, andadvantages be included within this description, be within the scope ofthe present disclosure, and be protected by the accompanying claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Many aspects of the disclosure can be better understood with referenceto the following drawings. The components in the drawings are notnecessarily to scale, emphasis instead being placed upon clearlyillustrating the principles of the present disclosure. Moreover, in thedrawings, like reference numerals designate corresponding partsthroughout the several views.

FIG. 1 is a schematic illustration of a method of sterilizing medicalinstruments within a hydrogen peroxide sterilization process, inaccordance with a first exemplary embodiment of the present disclosure.

FIG. 2 is a schematic illustration of a method of manufacturing andusing a sterilization tray, in accordance with a second exemplaryembodiment of the present disclosure.

FIG. 3 is a schematic illustration of a method of manufacturing andusing a sterilization tray, in accordance with the second exemplaryembodiment of the present disclosure.

DETAILED DESCRIPTION

FIG. 1 is a schematic illustration of a method of sterilizing medicalinstruments within a hydrogen peroxide sterilization process 10, inaccordance with a first exemplary embodiment of the present disclosure.The method of sterilizing medical instruments within a hydrogen peroxidesterilization process 10, which may be referred to herein simply as‘method 10’ includes housing a medical instrument 20 in a sterilizationtray 30, wherein the sterilization tray is formed from polypropylene anda glass material. The medical instrument 20 and sterilization tray 30are subjected to a hydrogen peroxide sterilant 40 within a hydrogenperoxide sterilization process 50.

Unlike a hydrogen peroxide sterilization process used with conventionalPPSU sterilization trays, which are prone to degrading after beingsubjected to hydrogen peroxide, it has been found that trays formed frompolypropylene (PP) and a glass material, such as glass fibers, glassspheres, or a combination thereof, can prove to be successful inhydrogen peroxide sterilization. The combination of PP and the glassmaterial resists penetration of the hydrogen peroxide into the surfaceof the tray, since the PP and glass material provide for a less poroussurface than conventional PPSU and glass trays. Thus, while PPSU absorbshydrogen peroxide in low-temperature, PP with glass does not.Accordingly, PP and glass material formed trays may be capable of longterm, successful use with hydrogen peroxide sterilization. Further, theprocess described herein may, in some situations, be used with ethyleneoxide or other chemical sterilants.

FIG. 2 is a schematic illustration of a method of manufacturing andusing a sterilization tray 110, in accordance with a second exemplaryembodiment of the present disclosure. The method of manufacturing andusing a sterilization tray 110, which may be referred to herein simplyas ‘method 110’ includes forming the medical sterilization tray 130 byinjection molding a polypropylene (PP) 120 and a glass material 122 intoa tray form. The PP 120 and the glass material 122 may be provided to aninlet 162 of an injection molding device 160. The PP 120 and glassmaterial 122 may be pre-mixed into a resin 126, without the addition ofcopolymers, prior to being fed into the inlet 162 of the injectionmolding device 160. Inside the injection molding device 160, thecombined resin may be injected into a mold having a tray-form shape,which may include any type of shape to house medical instruments. Theresulting tray 130 may then be used to sterilize medical instrumentswithin a low-temperature hydrogen peroxide sterilization device 150. Thesterilization device 150 receives an input of hydrogen peroxide 140which is applied to the tray 130 and the medical instruments thereon,and effectively sterilizes the instruments, as is known in the art.Alternatively, or in addition, the sterilization device 150 may receivean input of steam 144 for use in sterilization, and/or the sterilizationdevice may receive an input of a chemical sterilant including, but notlimited to an ethylene-oxide based sterilant 142.

In comparison to PPSU which is commonly used in medical sterilizationtrays, PP has a higher melt flow rate than PPSU and therefore PP isoften more successfully used in injection molding. It is noted that theglass material 122 may include a variety of types of glass fillers andother materials. Commonly, glass fibers, glass spheres, or a combinationof glass fibers and spheres may be used with the PP. The glass fillingmaterial 122 may provide rigidity to the eventual tray 130, such that itcan support medical instruments properly. Up to 30% of the sterilizationtray material may be glass fiber and/or glass spheres. While othermaterials and fillers may be included, the use of EVAL®, EVOH resin andfilm (ethylene vinyl alcohol copolymer) may be restricted or fullyomitted from the combined resin and the resulting tray 130.

FIG. 3 is a schematic illustration of a method of manufacturing andusing a sterilization tray 110, in accordance with the second exemplaryembodiment of the present disclosure. Similar to FIG. 2, the method 110includes forming the medical sterilization tray 130 by injection moldinga PP 120 and a glass material 122. However, the method of FIG. 3includes further injection molding the PP 120 and the glass material 122into a sheet form 124, first, and then thermoforming the sheet form 124of the PP 120 and the glass material 122 into a tray form.

In this process, the PP 120 and the glass material 122 may be providedto an inlet 162 of an injection molding device 160. The PP 120 and glassmaterial 122 may be pre-mixed into a resin, without the addition ofcopolymers, prior to being fed into the inlet 162 of the injectionmolding device 160. Inside the injection molding device 160, thecombined resin may be injected into a mold having a sheet form, e.g., asubstantially planar sheet that is sized for thermoforming. Once cooledfully, the sheet form of the combined resin may be placed in athermoforming device 180. Within the thermoforming device 180, the sheetform of the combined resin is heated to a pliable forming temperatureand formed to a tray-shape in a mold, which may include any type ofshape to house medical instruments. The tray-shape is trimmed to createa final medical sterilization tray 130, which may then be used tosterilize medical instruments within a low-temperature hydrogen peroxidesterilization device 150. The sterilization device 150 receives an inputof hydrogen peroxide 140 which is applied to the tray 130 and themedical instruments thereon, and effectively sterilizes the instruments,as is known in the art.

It has been found that thermoforming PP materials alone may result innon-usable products, since the PP is often incapable of withstanding thethermoforming process. The glass filling materials 122 may be used toproperly thermoform the sheet-form of the combined resin by helping thesheet-form of the combined resin maintain uniformity in shape. In oneexample, it has been found that the combined use of glass fibers andglass spheres may provide substantial benefits in maintaining uniformityduring the cool down process after thermoforming.

It should be noted that any process descriptions or blocks in flowcharts should be understood as representing modules, segments, or stepsthat include one or more instructions for implementing specific logicalfunctions in the process, and alternate implementations are includedwithin the scope of the present disclosure in which functions may beexecuted out of order from that shown or discussed, includingsubstantially concurrently or in reverse order, depending on thefunctionality involved, as would be understood by those reasonablyskilled in the art of the present disclosure.

It should be emphasized that the above-described embodiments of thepresent disclosure, particularly, any “preferred” embodiments, aremerely possible examples of implementations, merely set forth for aclear understanding of the principles of the disclosure. Many variationsand modifications may be made to the above-described embodiment(s) ofthe disclosure without departing substantially from the spirit andprinciples of the disclosure. All such modifications and variations areintended to be included herein within the scope of this disclosure andthe present disclosure and protected by the following claims.

What is claimed is:
 1. A method of sterilization for medical instrumentswithin a hydrogen peroxide sterilization process, the method comprising:housing a medical instrument in a sterilization tray, wherein thesterilization tray is formed from polypropylene and a glass material;and subjecting the medical instrument and sterilization tray to ahydrogen peroxide sterilant.
 2. The method of claim 1, wherein thesterilization tray is formed from polypropylene and the glass materialby: injection molding the polypropylene and the glass material into asheet form; and thermoforming the sheet form of the polypropylene andthe glass material into a tray form.
 3. The method of claim 2, furthercomprising: premixing the polypropylene and the glass material into aresin without the addition of copolymers prior to the injection molding.4. The method of claim 1, wherein the sterilization tray is formed frompolypropylene and the glass material by injection molding thepolypropylene and the glass material into a tray form.
 5. The method ofclaim 1, wherein the glass material includes one of glass fibers andglass spheres.
 6. The method of claim 1, wherein the sterilization trayincludes up to 30% glass material.
 7. The method of claim 1, furthercomprising: subjecting the medical instrument and sterilization tray toa steam sterilization.
 8. A method of manufacturing and using asterilization tray comprising: combining a quantity of polypropylenewith a glass material; injecting the combined quantity of polypropylenewith glass material into a sheet form; thermoforming the sheet form ofthe combined quantity of polypropylene with glass material into a trayform, thereby providing a sterilization tray; and subjecting thesterilization tray to a hydrogen peroxide sterilant.
 9. The method ofclaim 8, further comprising: premixing the polypropylene and the glassmaterial into a resin without the addition of copolymers prior to theinjection molding.
 10. The method of claim 8, wherein the sterilizationtray is formed from polypropylene and the glass material by injectionmolding the polypropylene and the glass material into a tray form. 11.The method of claim 8, wherein the glass material includes one of glassfibers and glass spheres.
 12. The method of claim 8, wherein thesterilization tray includes up to 30% glass material.
 13. The method ofclaim 8, further comprising: subjecting the medical instrument andsterilization tray to a steam sterilization.
 14. A method ofsterilization for medical instruments within a chemical sterilizationprocess, the method comprising: housing a medical instrument on asterilization tray, wherein the sterilization tray is formed frompolypropylene and a glass material; and subjecting the medicalinstrument and sterilization tray to at least one chemical sterilant.15. The method of claim 14, wherein the subjecting of the medicalinstrument and sterilization tray to a chemical sterilant includessubjecting the medical instrument and sterilization tray to an ethyleneoxide-based sterilant.
 16. The method of claim 14, wherein thesterilization tray is formed from polypropylene and the glass materialby: injection molding the polypropylene and the glass material into asheet form; and thermoforming the sheet form of the polypropylene andthe glass material into a tray form.
 17. The method of claim 16, furthercomprising: premixing the polypropylene and the glass material into aresin without the addition of copolymers prior to the injection molding.18. The method of claim 14, wherein the sterilization tray is formedfrom polypropylene and the glass material by injection molding thepolypropylene and the glass material into a tray form.
 19. The method ofclaim 14, wherein the glass material includes one of glass fibers andglass spheres, and wherein the sterilization tray includes up to 30%glass material.
 20. The method of claim 14, further comprising:subjecting the medical instrument and sterilization tray to a steamsterilization.